While, historically, alcohol production and sale were local matters, commercialised and industrialised alcohol has supervened, globalised initially through European empires, transforming alcohol’s place in everyday life. But alcohol was not included in the current international drug control system, initiated in 1912. In the current “UN system” of 35 intergovernmental agencies, alcohol has been a recurrent concern in the work only of the World Health Organization (WHO). Examples are given of the sporadic involvement in alcohol issues of other agencies, and the history of WHO’s involvement between 1950 and early 2020 is briefly described. At WHO, the place of alcohol programming in its structure and which other topics it is linked with have been recurrent issues. Civil society support for alcohol initiatives has been comparatively weak, and alcohol industry counter-pressure has been strong. Alcohol issues have thus received less attention at the intergovernmental level than the harm would justify. Constraining factors have included not only lobbying by industry interests, but also the multi-sectoral nature of alcohol problems and the international cultural position of alcohol as a luxury good served at gatherings of political and media elites.

This article analyses the administrative measures and, more specifically, the administrative strategy implemented in the immediacy of the emergency by the Italian government in order to determine whether it was effective in managing the COVID-19 pandemic throughout the country. In analysing the administrative strategy, the article emphasises the role that the current system of constitutional separation of powers plays in emergency management and how this system can impact health risk assessment. An explanation of the risk management system in Italian and European Union (EU) law is provided and the following key legal issues are addressed: (1) the notion and features of emergency risk regulation from a pandemic perspective, distinguishing between risk and emergency; (2) the potential and limits of the precautionary principle in EU law; and (3) the Italian constitutional scenario with respect to the main provisions regulating central government, regional and local powers. Specifically, this article argues that the administrative strategy for effectively implementing emergency risk regulation based on an adequate and correct risk assessment requires “power sharing” across the different levels of government with the participation of all of the institutional actors involved in the decision-making process: Government, Regions and local authorities.

This short paper aims to unpack some of the assumptions underlying the “Policy and Investment Recommendation for Trustworthy AI” provided by the High-Level Expert Group on Artificial Intelligence (AI) appointed by the European Commission. It elaborates in particular on three aspects: on the technical-legal dimensions of trustworthy AI; on what we mean by AI; and on the impact of AI. The consequent analysis results in the identification, amongst others, of three recurrent simplifications, respectively concerning the definition of AI (sub-symbolic systems instead of “intelligent” informational processing systems), the interface between AI and institutions (neatly separated instead of continuity) and a plausible technological evolution (expecting a plateau instead of a potentially near-disruptive innovation).

Since the International Agency on Cancer Research’s monograph found glyphosate to be a likely carcinogen, the regulatory focus on the chemical has centred on this determinative criterion for regulatory action. Yet, other pertinent factors, such as the effects of glyphosate on fresh and ground water and ensuing effects on biodiversity, have received less attention as legitimate rationales for regulating the chemical. This underrepresentation prevents a wider policy discussion on the environmental and human health effects of the chemical and fails to disrupt assumptions of path-dependently continuing on agriculture’s chemical treadmill. To avoid ad hoc post hoc chemical regulation, we assess four areas of chemical regulatory oversight in Europe with regard to glyphosate affecting water: (1) the undue emphasis on in laboratorio versus in situ testing; (2) assessing single chemicals (isolated glyphosate) versus admixtures (glyphosate plus surfactants and adjuvants) that are used in practice; (3) the tendency to downplay harms to non-human life; and (4) the lack of policy coherence in the existing regulatory framework. Focusing on European Union regulation of pesticide and water policy affecting aquatic environments, we conclude that issues of measurement and priority have become highly politicised in both science and policy, requiring preventative, precautionary frameworks utilising plural forms of measurement.

This contribution will draw on the literature that has accumulated on how the Court of Justice of the European Union (CJEU) has responded to the European Banking Union, which was established in similar crisis circumstances that now face the European Union (EU) in the age of COVID-19, to illustrate the legal issues on which the CJEU’s input will be particularly important in the shaping of any future European Health Union. This contribution will highlight three legal issues in particular: the interpretation of EU Treaty provisions in the health field; the scope of EU competence; and the powers of EU institutions and agencies. This contribution will argue that the CJEU case law to date on health issues is encouraging with respect to competence and agencies, but more cautious with respect to the Treaty’s health provisions.

This article discusses the role of European Union (EU) State aid law in the COVID-19 crisis. It contends that different Treaty derogations have played unique roles in addressing the core determinants of the economic risk linked to the pandemic (ie the “exposure” to lockdown measures and the “vulnerability” of certain sectors to them), and in increasing the resilience of national economies. Moreover, this article examines the extent to which EU State aid law has been used to manage and mitigate health risks, by allowing Member States to enhance the preparedness and capacity of their healthcare sector (broadly conceived) to respond to the pandemic. On the whole, this article maintains that State aid control has been used by the European Commission as an important “risk management tool”, and it highlights the role of the Commission as the crisis management authority.

The recent reauthorisation of glyphosate in the European Union is a uniquely suitable opportunity to study the relationships between law and science because, unlike many other controversies that are commonly perceived through the science/democracy dichotomy, in this case the disagreement was between the “scientific” assessments of two purely “expert” bodies, the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA). This paper takes a close look at some details of the two assessments to show how scientific assessments are shaped by the legal environment to such an extent that it is impossible to separate “legal” from “technical” issues at any level; they are entangled together “all the way down”. Furthermore, it identifies three side effects of this entanglement that were previously unnoticed. First, obscure legal rules may provide (usually unintended) leverage to some of the parties. In turn, this forces everybody into proxy wars on the issue where the leverage is, at the expense of all other concerns that they may legitimately have. Finally, despite the strict legal regimentation of the scientific assessment, significant space for judgment remains, and discretion is never removed, only shifted to different places or levels.

Contemporary risk regulation requires an interdisciplinary approach that integrates science, law and socio-political discourses. This calls for new tools in the risk regulation process that enable regulators to adapt to a constantly changing technological realm and help overcome the interdisciplinarity dilemma. In the field of nanotechnologies, tools proposed in the literature include “by design” approaches. In this article, I analyse how the safe-by-design and benign-by-design concepts, emerging in materials science and drug development, could enhance interdisciplinarity in risk regulation. I suggest that further development and implementation of “by design” from a scientific concept to an adaptive regulatory tool could support progressive risk governance of innovative technological developments and enhance the interdisciplinary approach in risk regulation.

A multitude of medical products are being developed and produced as part of efforts to tackle COVID-19. They are varied in nature and range from test kits to tracing apps, protective equipment, ventilators, medicines and, of course, vaccines. The design, testing and manufacture of many of these products differs from production in normal times due to the urgency of the situation and the rapid increase in demand created by the pandemic. This article considers the legal issues arising as a result of the production of emergency products, particularly from a products liability perspective. To what extent do existing concepts under the European Product Liability Directive, such as defect, causation and the various defences, permit the pandemic to be taken into account when a Court is considering issues of liability? What is the impact on liability of the modified regulatory regime? In light of that discussion, the case for alternative responses is examined from a comparative and European perspective, including the issue of Government indemnities for the manufacturers of products, legal exemptions from liability and alternative no-fault compensation schemes.

In the COVID-19 pandemic, whistleblowers have become the essential watchdogs disrupting suppression and control of information. Many governments have intentionally not disclosed information or failed to do so in a timely manner, misled the public or even promoted false beliefs. Fierce public interest defenders are pushing back against this censorship. Dr Fen and Dr Wenliang were the first whistleblowers in China to report that a new pandemic was possibly underway, and ever since, numerous other whistleblowers around the world have been reporting on the spread of the virus, the lack of medical equipment and other information of public interest. This paper maps the relevant whistleblowing cases in China, the USA and Europe and shows that many whistleblowers are initially censored and face disciplinary measures or even dismissals. At the same time, whistleblowing during the COVID-19 pandemic has drawn public attention to the shortcomings of institutional reporting systems and a wider appreciation of whistleblowers as uniquely placed to expose risk at early stages. Ultimately, whistleblowing as a means of transparency is not only becoming ever less controversial, but during COVID-19 it has become the “remedy” to censorship.

On 17 March 2020, the President of the European Council, Charles Michel, and the President of the European Commission (hereinafter, Commission), Ursula von der Leyen, announced further European Union (EU) actions in response to the COVID-19 outbreak. Since the pandemic reached Europe, the EU has adopted a number of trade-related measures, including the issuance of guidelines for national border management, as well as export authorisation requirements. On 14 March 2020, the Commission adopted “Commission Implementing Regulation (EU) 2020/402 of 14 March 2020 making the exportation of certain products subject to the production of an export authorisation”, temporarily restricting exports of “personal protective equipment” to destinations outside of the EU. On 14 April 2020, the Commission announced that it would narrow down export authorisation requirements to protective masks only and extend the geographical and humanitarian exemptions. Governments around the world have been implementing trade-related measures in response to the COVID-19 pandemic, some trade restrictive, but a number of countries have also called for the elimination of export controls and restrictions on essential goods. As the greater implications of the COVID-19 pandemic on trade are still difficult to assess, the emergency measures taken by affected countries already require legal scrutiny. At the same time, it must be noted that, as noted above for the EU measures, measures around the world are subject to change dynamically in view of the evolution of the pandemic.

Amid the outbreak of the SARS-CoV-2 pandemic, there has been a call to use innovative digital tools for the purpose of protecting public health. There are a number of proposals to embed digital solutions into the regulatory strategies adopted by public authorities to control the spread of the coronavirus more effectively. They range from algorithms to detect population movements by using telecommunications data to the use of artificial intelligence and high-performance computing power to detect patterns in the spread of the virus. However, the use of a mobile phone application for contact tracing is certainly the most popular.

Due to its borderless nature, COVID-19 has been a matter of common European interest since its very first detection on the continent. Yet this pandemic outbreak has largely been handled as an essentially national matter. Member States adopted their own different, uncoordinated and at times competing national responses according to their distinctive risk analysis frameworks, with little regard1 for the scientific and management advice provided by the European Union (EU), notably its dedicated legal framework for action on cross-border health threats.2 To justify such an outcome as the inevitable consequence of the EU’s limited competence in public health is a well-rehearsed yet largely inaccurate argument3 that calls for closer scrutiny.

A number of virological, epidemiological and ethnographic arguments suggest that COVID-19 has a zoonotic origin. The pangolin, a species threatened with extinction due to poaching for both culinary purposes and traditional Chinese pharmacopoeia, is now suspected of being the “missing link” in the transmission to humans of a virus that probably originated in a species of bat. Our predation of wild fauna and the reduction in their habitats have thus ended up creating new interfaces that favour the transmission of pathogens (mainly viruses) to humans. Domesticated animals and wild fauna thus constitute a reservoir for almost 80% of emerging human diseases (SARS-CoV, MERS-CoV, Ebola). These diseases are all zoonotic in origin. As if out of a Chinese fairy tale, the bat and the pangolin have taught us a lesson: within an increasingly interdependent world, environmental crises will become ever more intertwined with health crises. Questions relating to public health will no longer be confined to the secrecy of the physician’s consulting room or the sanitised environment of the hospital. They are now being played out in the arena of international trade, ports and airports and distribution networks. Simply put, all human activity creates new interfaces that facilitate the transmission of pathogens from an animal reservoir to humans. This pluri-disciplinary article highlights that environmental changes, such as the reduction in habitats for wild fauna and the intemperate trade in fauna, are the biggest causes of the emergence of new diseases. Against this background, it reviews the different measures taken to control, eradicate and prevent the emergence of animal diseases in a globalised world.

This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered way, the shortage of resources seems to have acted as a driver of coordination, which is now increasingly being discussed at EU level. I will examine the legal and institutional framework supporting such embryonic coordination efforts and offer a preliminary assessment of their implications for a European approach to epidemiological knowledge-making.

The world economy is sliding yet into another recession (having arguably barely recovered from the previous economic downturn) due to the worldwide pressures and tensions created by the COVID-19 pandemic.1 With most countries in the world under lockdown (or in similar situations), almost all food is now consumed in the household. Arguably, agricultural producers and the retail industry appear to be the best placed to weather the storm in order to respond to such a change in demand. However, this is overly simplistic. Recent news of empty shelves in supermarkets whilst dairy farmers have been forced to pour milk down the drain have gone viral.

This contribution analyses whether the Court of Justice of the European Union (CJEU) provides clarifications on the normative implications that the precautionary principle entails in the context of Regulation 1107/2009, laying out the EU authorisation procedure for pesticides, in its recent judgement in Case C-616/17. In this judgement, which is a response to a request for a preliminary ruling by a French criminal court on the compatibility of certain aspects of Regulation 1107/2009 with the precautionary principle, the CJEU concludes that the questions of the referring court reveal nothing capable of affecting the validity of the regulation. According to the CJEU, to ensure conformity with the precautionary principle, the EU legislature must establish a normative framework that makes available to competent authorities sufficient information to adequately assess the risks to health resulting from the pesticide in question. However, the CJEU’s substantive analysis of the compatibility of the different aspects of Regulation 1107/2009 with the precautionary principle is not conducted concretely in light of this legal standard, but constitutes a mere testing of the general adequacy of Regulation 1107/2009. Furthermore, the CJEU’s judgement examines Regulation 1107/2009 in a vacuum without considering problems that have occurred in its implementation or application.